Director, Late Stage Clinical Development

Responsibilities

• Lead aspects of the global strategy for Expanded Access Programs and Late-Stage development, aligned with asset lifecycle objectives, patient access goals, and regulatory expectations
• Partner with the Executive Director Late-Stage Clinical Strategy, Clinical Development, Clinical Operations, HEOR, Medical Affairs, Regulatory Affairs, Commercial, Asset Strategy Lead and Program Leadership to ensure Expanded Access Program and Late-Stage clinical activities are fully integrated into the overall asset strategy
• Lead the development and implementation of Expanded Access Programs, including protocol development, eligibility criteria, safety oversight, and operational execution
• Collaborate with cross-functional planning team to ensure Expanded Access Programs are compliant, scalable, ethically sound, and aligned with regulatory guidance
• Provide consultation to benefit-risk assessment, safety monitoring, and ongoing program evaluation
• Support the development of the late-stage clinical evidence generation strategy objectives, including real-world evidence generation, long-term safety, effectiveness, and differentiation in the treatment landscape
• Lead the design, planning, and execution of the late-stage clinical evidence program, including protocol development, data collection strategies, and interpretation of outcomes for Phase 4 and investigator-initiated trials
• Ensure late-stage clinical program designs address regulatory commitments, payer needs, and scientific gaps

Qualifications

• Doctoral degree required (MD, PhD, PharmD, PsyD)
• 6-8+ years of clinical development experience in the pharmaceutical or biotechnology industry
• Demonstrated experience leading Expanded Access programs and late-stage, post-approval programs
• Experience selecting and managing third-party vendors to support operational functions of Expanded Access and late-stage evidence programs
• CNS clinical development experience in psychiatry strongly preferred